Идёт набор NCT07125274

Sputum-free Diagnostis of TB

— Наблюдательное Tuberculosis

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Biomarker-guided diagnostic tests.
Кому может быть актуально: Состояния в реестре: Tuberculosis. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Германия
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Biomarker-guided Diagnosis of Tuberculosis

Обзор

The aim of this study is to identify new biomarkers that enable reliable, non-invasive diagnosis of tuberculosis (TB), including in patients who are unable to produce sputum. The study analyzes biomaterials (blood, urine, stool, sputum) collected from patients with suspected TB. Various diagnostic methods are applied to assess the feasibility of individual and combined biomarker tests. Participating patients will provide biomaterial samples (blood, urine, stool, sputum) once. No additional examinations or invasive procedures will be performed. Routine diagnostic procedures remain unaffected. This is a single-center, prospective observational study. Patients are enrolled as part of their clinical care at the University Medical Center Hamburg-Eppendorf.

Вмешательства

Диагностический тест Biomarker-guided diagnostic tests
mRNA-Signature from blood; immunophenotyping from blood; MBLA from sputum, PATHFAST-LAM and EclLAM from sputum, stool, urine; CRISPR-Cas from blood; stool PCR; QuantiFERON(R)-TB Gold Plus.

Первичные конечные точки

Feasibility of biomarker-guided diagnosis of TB - mRNA signatures [Срок оценки: From enrollment to the end of the first week of treatment]
Feasibility of biomarker-guided diagnosis of TB - cellular immunology [Срок оценки: From enrollment to the end of the first week of treatment]
Feasibility of biomarker-guided diagnosis of TB - PATHFAST-LAM [Срок оценки: From enrollment to the end of the first week of treatment]
Feasibility of biomarker-guided diagnosis of TB - EclLAM [Срок оценки: From enrollment to the end of the first week of treatment]
Feasibility of biomarker-guided diagnosis of TB - cell-free Mycobacterium tuberculosis DNA [Срок оценки: From enrollment to the end of the first week of treatment]
Feasibility of biomarker-guided diagnosis of TB - MBLA [Срок оценки: From enrollment to the end of the first week of treatment]
Feasibility of biomarker-guided diagnosis of TB - stool PCR [Срок оценки: From enrollment to the end of the first week of treatment]
Feasibility of biomarker-guided diagnosis of TB - composit [Срок оценки: From enrollment to the end of the first week of treatment]

Вторичные конечные точки (4)

Exploratory Analysis of Biomarker Profiles and Their Clinical Associations [Срок оценки: From enrollment to the end of the first week of treatment.]
Exploratory Analysis of Biomarker Profiles and Their Clinical Associations [Срок оценки: From enrollment to the end of the first week of treatment.]
Exploratory Analysis of Biomarker Profiles and Their Clinical Associations [Срок оценки: From enrollment to the end of the first week of treatment.]
Exploratory Analysis of Biomarker Profiles and Their Clinical Associations [Срок оценки: From enrollment to the end of the first week of treatment.]

Критерии участия

Критерии включения

Suspected pulmonary or extrapulmonary tuberculosis, or confirmed pulmonary or extrapulmonary tuberculosis with less than 7 days of anti-tuberculosis treatment, OR other pulmonary infection (control group).
Age ≥ 18 years
Ability to provide informed consent
Willingness to participate in the study